USA: BIDEN Administration plans for legal legal psychedelic therapies within two years

 

A letter from the Health and Human Services Department discloses the anticipated FDA approval of MDMA and psilocybin treatments.

As twwin mental health and drug misuse crises kill thousands of people per week, the potential of psychedelic-assisted therapies “must be explored,” urges a federal letter on behalf of the U.S. health secretary and shared with The Intercept. 

 

President Joe Biden’s administration “anticipates” that regulators will approve MDMA and psilocybin within the next two years for designated breakthrough therapies for PTSD and depression, respectively. The administration is “exploring the prospect of establishing a federal task force to monitor” the emerging psychedelic treatment ecosystem, according to the letter sent by Assistant Secretary for Mental Health and Substance Use Miriam Delphin-Rittmon to Rep. Madeleine Dean, D-Pa.

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The May correspondence, not shared publicly until now, is the clearest indication yet that top officials are preparing for the approval of psychedelic drugs — demonized for decades after former President Richard Nixon sought means to attack the anti-Vietnam War counterculture in the late 1960s — which was arguably unthinkable even five years ago.

But as evidence grows of the healing potential of certain controlled substances, including many hallucinogens, the war on drugs in the U.S. is steadily being wound down. Late Friday, the Drug Enforcement Agency dropped plans to schedule several DMT analogues after facing serious opposition, including a legal threat from companies Mindstate, Tactogen, and Panacea Plant Sciences.

The move followed Thursday’s introduction of a bipartisan bill, co-sponsored by Sens. Cory Booker, D-N.J., and Rand Paul, R-Ky., to force the DEA to stop barring terminally ill patients from trying controlled drugs which have passed early trials. The right to try experimental therapies has been enshrined in federal law since 2018, but the DEA currently blocks its use among people with late-stage cancer who wish to be treated with psilocybin, a Schedule I controlled substance.

“Studies have shown that psilocybin produces substantial and sustained decreases in depression and anxiety among patients with life-threatening cancer,” Booker wrote in a statement tweeted Thursday. “While typically terminally ill patients are allowed to access drugs that are in FDA clinical trials, they are barred from accessing Schedule I drugs, despite their therapeutic potential.”

In the letter obtained by The Intercept, Delphin-Rittmon said that the Substance Abuse and Mental Health Services Administration, or SAMHSA, responding to Dean on behalf of Health and Human Services Secretary Xavier Becerra, “agrees that too many Americans are suffering from mental health and substance use issues, which have been exacerbated by the ongoing COVID-19 pandemic, and that we must explore the potential of psychedelic-assisted therapies to address this crisis.”

Dean had proposed an interagency task force, the letter notes, to lead a public-private partnership and address “the myriad of complex issues associated with the anticipated approval by the [FDA] of [MDMA] for the treatment of post-traumatic stress disorder and psilocybin for the treatment of depression within approximately 24 months.”

According to Delphin-Rittmon, SAMHSA and the assistant secretary for health are considering the establishment of such a task force including the private sector. “Collaboration across federal agencies with outside stakeholders will be the most effective way to ensure we are thoughtfully coordinating work on emerging substances such as MDMA and psilocybin,” she wrote. 

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